Medical device maker Olympus has just recalled thousands of its duodenoscopes, which have been linked to multiple outbreaks of this deadly disease.
Medical device manufacturer Olympus is about to be in hot water. According to a report from UPI, the company has just announced that it will voluntarily recall shipments of surgical scopes that were believed to be responsible for transmitting a deadly infection.
The U.S. Food and Drug Administration recently approved Olympus’ plans to redesign their duodenoscopes, which would address design flaws that facilitated the transmission of a germ called CRE, or carbapenem-resistant Enterobacteriaceae.
A duodenoscope is used to drain the fluids from backed up pancreatic and biliary ducts. They are extremely common devices, and are used as a non-invasive first attempt at treating blockage to avoid the need for surgery.
While the tool is extremely useful, it has been found by a Senate investigation to be linked to at least 25 separate CRE outbreaks, infecting over 140 people across the U.S. Three patients at the University of California, Los Angeles even died from their infections, which resisted normal antibiotic treatments.
Senate investigators allege that the company was aware of the design flaws in their duodenoscopes that lead to the transmission of CRE as early as 2012. The company, allege investigators, failed to warn their customers or take any sort of action to address the possibility of a CRE outbreak as a result of using their scopes.
“It infuriates me to know they knew about this in 2012,” said Steven Wilkinson-St. George, a patient who contracted CRE after being treated with an Olympus duodenoscope. “This should have been done years ago.”
The company currently manufactures roughly 85 percent of all duodenoscopes, with the remaining 15 percent produced by Pentax and Fuji. It remains unclear whether these two firms will step up and help to supply more scopes during the recall.
Olympus denies any wrongdoing in the matter, saying that those who contracted CRE infections were victims of improper cleaning procedures and not a specific design flaw. “Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with the use of Olympus duodenoscopes,” said a company statement.
A press release from the FDA regarding the recent device recall can be found here.